A clinical trial is very expensive business. The studies stated the cost of this clinical trial process is up to 60 per cent of the total drug development cost. Clinical trials are basically the experiments done in the clinical research where biomedical interventions include treatments such as vaccines, dietary supplements, drugs and some medical devices. Clinical trials can differ in size and cost, which involve a single or multiple research centres in our or multiple countries.
What makes clinical trial supply expensive? The transportation and logistics services that can amount for as much as 30 per cent of drug development cost. Due to strict handling requirements for many bio-pharmaceutical, the logistics of clinical trial supplies are more critical than ever. The process of this trial supply is led by the assigned clinical logistic leaders who are the experts having experience and expertise to confirm the quality of the drug is actually what you need. Clinical trial supply management team generates data on safety and efficacy. They start the process only after they have received health authority approval in the country. These authorities are responsible for examining the risk or benefit ratio of the trial but it doesn’t stand that the drug is safe, it only means that the trial may be conducted. Here, certain functions are indeed to the trial supply process, such as monitoring and lab experiments managed by the governmental organization or pharmaceutical company.
Expert management team begins with the clinical trial supply strategy.
The key for the perfect trial supply:
• To avoid information gaps and
• To trace the drug supply drug supply from manufacturing to dispensation and demolition
The services include:
• Comparator sourcing
• Supply coordination
• Outsourcing of supplied resources
• Labelling including booklets
• Designing patient packs
• Storage temperature
• Testing and managing
• Worldwide distribution
• Drug accountability
Following are the advantages of clinical trial supply:
• Expertise and experience to manage any type and size of drug trial
• Holistic management of the whole clinical supply chain
• global and local label text translation capacities
• Drug production coordination
• Taking responsibility on behalf of sponsor
• Distributes materials to warehouses, and trial sites (Worldwide)
• Monitoring shipments
• Maintain inventory
• Data-Warehouse management system (DWMS)
• Standardized return
• Perfect destruction procedures
There must be harmonized approach for this drug trial supply so that weak links can be eliminated and good practices are to be followed. One should have advanced planning and effective partnership to get the success. Both of these aspects will lead to improve the results. For the betterment, the client should have more information about the role and the component so they can obtain the best result and can streamline the cost.
Following are the Therapeutic areas where clinical trials can be worked:
• Pain, etc
Here, for particular regions, products and trials must use local depots/ warehouses. Therefore, the experts need to be sound about the whole process of clinical trial supply from the experiments to the regions.